Senior GCP Auditor (Biotech)

Location: Remote; 25%–30% travel may be required.

Annual base pay: $140,000–$154,000 for the national market or $145,500–$160,000 in premium markets, including Los Angeles, San Diego, San Francisco, New York City, Chicago, and Boston. Discretionary bonus and equity award may be available.

Company

hirify.global is a publicly traded biotechnology company developing immunotherapies, cell therapies, cancer vaccines, and treatments for infectious diseases.

What you will do

• Maintain and update the clinical trial Quality Management System in line with industry standards, ICH GCP, FDA regulations, and company procedures.
• Plan, coordinate, and conduct vendor, supplier, internal, for-cause, compliance, and clinical trial site audits.
• Prepare audit plans, reports, certificates, corrective action plans, and follow-up documentation.
• Manage complaints, deviations, CAPAs, audit findings, and related quality tracking records.
• Review protocols, amendments, informed consent forms, pharmacy manuals, clinical study reports, and other trial documentation.
• Support inspection readiness, regulatory inspections, training, and cross-functional resolution of GCP compliance issues.

Requirements

• Bachelor’s degree in life sciences or engineering and at least 7 years of experience in a GCP biologics or pharmaceutical environment, or a master’s degree and at least 4 years of relevant experience.
• Demonstrated understanding and application of ICH GCP E6 (R2) requirements.
• Strong planning, organization, problem-solving, analytical, communication, and documentation skills.
• Ability to manage multiple projects and work across Clinical Operations, Regulatory, Pharmacovigilance, Medical Writing, Data Management, and Medical Affairs.
• Flexibility to work off-hours, second shifts, and weekends when required.

Nice to have

• CQA or another audit certification.
• Experience with Trial Master File systems or electronic document management systems.

Culture & Benefits

• Remote work with a collaborative environment spanning multiple company functions.
• Professional development opportunities in a growing biopharmaceutical company.
• Medical, dental, vision, life, disability, wellness, and employee assistance programs.
• 401(k) retirement plan with company match and flexible spending accounts.
• Paid time off, holidays, education savings support, legal services, identity theft protection, pet insurance, and employee discounts.